A coronavirus vaccine may be available on an emergency basis in the fall if it proves to be safe during testing, Pfizer Inc announced on Tuesday. Vaccine testing, which has already started in Germany, could start in the US next week if health authorities agree, Pfizer CEO Albert Bourla said in an interview. The results of the study could then be available next month.
Pfizer needs to do more tests to make sure the vaccine works safely. If all tests are successful, Pfizer could start distributing the vaccine on an emergency basis in the fall - and get approval for large-scale distribution by the end of the year, Bourla said.
Pfizer works with the Mainz-based biotechnology company BioNTech to develop the vaccine. BioNTech announced last week that it had received approval for the first clinical trial of a COVID-19 vaccine in Germany.
The Mainz-based biotech company and the US pharmaceutical giant have started the clinical trial of their COVID-19 vaccine candidate BNT162. Twelve study participants in Germany have been vaccinated with BNT162 since the start of the study on April 23, 2020, as the two companies announced. This concludes the first dose cohort.
In order to find the optimal dose for the further studies, about 200 healthy volunteers between the ages of 18 and 55 should be vaccinated, the dose range is 1 to 100 micrograms. The safety and immunogenicity of the vaccine will also be investigated. Subjects at higher risk for a severe course of COVID-19 infection are included in the second part of the study.
The study is the first clinical trial of a vaccine candidate against the lung disease COVID-19 caused by the novel coronavirus in Germany. The two companies expect approval of studies for BNT162 in the United States shortly.
BioNTech and Pfizer are working together to develop BNT162. BioNTech will ensure clinical delivery of the vaccine through its manufacturing facilities in Europe. The company is also working with Fosun Pharma to develop BNT162 in China, where the companies plan to conduct clinical trials.
Artical:finanzen.net
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